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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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10/17/1997

[Federal Register: October 17, 1997 (Volume 62, Number 200)]

[Notices]

[Page 54117]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr17oc97-117]

 

[[Page 54117]]

 

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

Food and Drug Administration

[Docket No. 95N-0070]

 

Hedviga Herman; Debarment Order

 

AGENCY: Food and Drug Administration, HHS.

 

ACTION: Notice.

 

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order

under the Federal Food, Drug, and Cosmetic Act (the act) permanently

debarring Ms. Hedviga Herman, 1326 42d St., Brooklyn, NY 11219, from

providing services in any capacity to a person that has an approved or

pending drug product application. FDA bases this order on a finding

that Ms. Herman was convicted of a felony under Federal law for conduct

relating to the regulation of a drug product under the act. Ms. Herman

has failed to request a hearing and, therefore, has waived her

opportunity for a hearing concerning this action.

 

EFFECTIVE DATE: October 17, 1997.

 

ADDRESSES: Application for termination of debarment to the Dockets

Management Branch (HFA-305), Food and Drug Administration, 12420

Parklawn Dr., rm. 1-23, Rockville, MD 20857.

 

FOR FURTHER INFORMATION CONTACT:  Christine F. Rogers, Center for Drug

Evaluation and Research (HFD-7), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-2041.

 

SUPPLEMENTARY INFORMATION:

 

I. Background

    

On September 23, 1994, the United States District Court for the

District of Maryland entered judgment against Ms. Hedviga Herman for,

among other counts: (1) One count of introducing adulterated drugs into

interstate commerce, a Federal felony offense under 21 U.S.C. 331(a)

and 333(a)(2); (2) one count of introducing unapproved new drugs into

interstate commerce, a Federal felony offense under 21 U.S.C. 331(d)

and 333(a)(2); and (3) one count of obstruction of an agency

proceeding, a Federal felony offense under 18 U.S.C. 1505.

 

As a result of these convictions, FDA served Ms. Herman by

certified mail on February 20, 1996, a notice proposing to permanently

debar her from providing services in any capacity to a person that has

an approved or pending drug product application, and offered her an

opportunity for a hearing on the proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of the act (21 U.S.C.

335a(a)(2)(B)), that she was convicted of a felony under Federal law

for conduct relating to the regulation of a drug product. Ms. Herman

was provided 30 days to file objections and request a hearing. Ms.

Herman did not request a hearing. Her failure to request a hearing

constitutes a waiver of her opportunity for a hearing and a waiver of

any contentions concerning her debarment.

 

II. Findings and Order

    

Therefore, the Director, Center for Drug Evaluation and Research,

under section 306(a)(2)(B) of the act, and under authority delegated to

her (21 CFR 5.99), finds that Ms. Hedviga Herman has been convicted of

a felony under Federal law for conduct relating to the regulation of a

drug product.

 

As a result of the foregoing finding, Ms. Hedviga Herman is

permanently debarred from providing services in any capacity to a

person with an approved or pending drug product application under

section 505, 507, 512, or 802 of the act (21 U.S.C. 355, 357, 360b, or

382), or under section 351 of the Public Health Service Act (42 U.S.C.

262), effective October 17, 1997 (sections 306(c)(1)(B) and

(c)(2)(A)(ii) and 201(dd) of the act (21 U.S.C. 321(dd))). Any person

with an approved or pending drug product application who knowingly uses

the services of Ms. Herman, in any capacity, during her period of

debarment, will be subject to civil money penalties (section 307(a)(6)

of the act (21 U.S.C. 335b(a)(6))). If Ms. Herman, during her period of

debarment, provides services in any capacity to a person with an

approved or pending drug product application, she will be subject to

civil money penalties (section 307(a)(7) of the act). In addition, FDA

will not accept or review any abbreviated new drug applications

submitted by or with the assistance of Ms. Herman during her period of

debarment.

 

Any application by Ms. Herman for termination of debarment under

section 306(d)(4) of the act should be identified with Docket No. 95N-

0070 and sent to the Dockets Management Branch (address above). All

such submissions are to be filed in four copies. The public

availability of information in these submissions is governed by 21 CFR

10.20(j). Publicly available submissions may be seen in the Dockets

Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    

Dated: October 1, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

[FR Doc. 97-27586 Filed 10-16-97; 8:45 am]

BILLING CODE 4160-01-F